Basic Training (English)
Good Clinical Practice (GCP) is the ethical and scientific basis for the planning, preparation, conduct and reporting of clinical trials. GCP defines the principles for any clinical trial conducted with medicinal products. GCP has been introduced by ICH (International Council on Harmonization) in 1997 and has just recently been revised.
The seminar will include presentations with many practical examples as well as workshops on the most important topics of GCP. The trainer will focus on the responsibilities of the study sponsor (e.g. pharmaceutical or biotech company) but will also cover those elements that are of importance for the investigational team at the study site, i.e. at the hospital or private practice.
Topics
History and development of GCP; differentiation between clinical trial and non-interventional study; responsibilities of study sponsors including risk-based approach, quality management (quality assurance and quality control); responsibilities of the investigator in practical terms; submission to ethics committees and competent authorities; preparation, conduct, and reporting of a clinical trial with medicinal products.
Duration
The qualification will comprise a total of 7,0 hours which will be held from 9:00 a.m. to 05:00 p.m.
Size
The course will be held with a minimum of 6 and a maximum of 16 attendees.
Target Audience
The course is directed
- to staff from pharmaceutical or biotech companies starting or planning to start clinical development programs having no or little experience with the current GCP requirements,
- to natural scientists, PhD students and Postdocs of natural scientific and medical degree programs who are interested in getting an overview on GCP.
Learning Goals
After course completion, attendees will have developed a basic understanding of GCP requirements for the planning, preparation, and conduct of clinical trials with medicinal products. Thus, based on their individual background, attendees should also be able to identify potential occupational fields in the industry dealing with GCP topics.
Successful participation will be certified by the Gläsernes Labor Akademie (GLA).
Course fees
358,00 € per participant plus VAT.
Private registrees will get a fee reduction of about 10%.
According to local law (Berliner Bildungszeitgesetz BiZeitG) the course can be classed as educational leave.
Further information
Dr. Uwe Lohmeier per E-Mail: u.lohmeier@campusberlinbuch.de
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Version 15 Nov 2022
Subject to modifications